Transcatheter aortic valve replacement (TAVI) was associated with much better outcomes than standard care in patients with severe aortic disease unable to undergo surgery in the PARTNER trial.
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The trial, presented at the Transcatheter Cardiovascular Therapeutics (TCT) meeting in Washington DC, US, in September, has also now been published (N Engl J Med 2010;363:1597-1607).
The PARTNER investigators explain that aortic stenosis is associated with a high rate of death (approximately 50% in the first two years after symptoms appear) among untreated patients. While surgical replacement of the aortic valve reduces symptoms and improves survival, at least 30% of patients are unable to undergo surgery because of advanced age, left ventricular dysfunction, or the presence of multiple coexisting conditions.
For these patients, the less invasive procedure of TAVI has been available since 2002. In this procedure a bioprosthetic valve is inserted through a catheter and implanted within the diseased native aortic valve. But until now there have not been any rigorous, evidence-based clinical data to substantiate the benefits of TAVI as compared to standard therapies.
In the PARTNER trial, 358 patients unsuitable for surgery were randomised to either transcatheter valve implantation or standard care, including balloon valvuloplasty
Results (table 1) showed that although strokes and major vascular complications were higher in the TAVI group in the first 30 days, at one year there were impressive reductions in the TAVI group for all-cause mortality and the composite end point of death or repeat hospitalisation.
The authors note that only five patients needed to be treated to prevent one death, and only three patients needed to be treated to prevent either a death or repeat hospitalisation.
“On the basis of a rate of death from any cause at one year that was 20 percentage points lower with TAVI than with standard therapy, balloon-expandable TAVI should be the new standard of care for patients with aortic stenosis who are not suitable candidates for surgery,” the PARTNER authors conclude.
A second part of the trial comparing TAVI with surgical valve replacement in high-risk patients is still ongoing.